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Xofluza (baloxavir marboxil)
药品名称
Xofluza (baloxavir marboxil)
承诺描述
Submit the full clinical study report and datasets for Study T0835 conducted to evaluate the pharmacokinetics, safety, and effectiveness of baloxavir marboxil for the treatment of acute, uncomplicated influenza in Japanese pediatric subjects < 12 years of age and < 20 kilograms in weight. The study report should include characterization of the emergence of baloxavir resistant viral variants, including supportive datasets